CTRI/2010/091/001128已完成4 期
A Phase IV, Multicentric, Controlled, Open labeled, Study to Evaluate the Safety and Immunogenicity of ComVac5 (DTwP-Hep-B-Hib-Liquid Pentavalent vaccine of BBIL) Vs. Reference Vaccine in healthy subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Parent/guardian of subject willing to give written informed consent and to comply to all study related procedures and visits.
- •2)Healthy male or female infant aged 6 to 8 weeks at the time of screening/enrollment.
- •3)Subjects who are healthy without any history of DTP and Hib vaccination. (As Hepatitis B vaccination is often done at birth, history of immunization against Hepatitis B at birth is not a parameter for exclusion but the fact is recorded in the case record form).
- •4)Infant who is HBsAg negative.
- •5)Subjects should have been born after 36-week term and are not less than 3200 gms, at the time of inclusion.
排除标准
- •1)Fever of any origin of duration more than 3 days prior to/at screening visit.
- •2)Past history of DTP & Hib vaccination.
- •3)History of acute or chronic auto immune disease.
- •4)Any confirmed or suspected immunosuppressive condition.
- •5)Any treatment with immunosuppressive or immuno stimulant therapy
- •6)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for DTP Hepatitis B and Hib.
- •7)Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
- •8)Known hypersensivity reactions to any of the components of the vaccine.
研究者
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